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e-CFR data is current as of January 14, 2021

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5620


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices


§864.5620   Automated hemoglobin system.

(a) Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

(b) Classification. Class II (performance standards).

[45 FR 60601, Sept. 12, 1980]

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